FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Revolution CT, Revolution CT ES
- Recall number
- Z-0816-2022
- Recalling firm
- GE Healthcare, LLC
- Product
- Revolution CT, Revolution CT ES
- Status
- Open, Classified
- Initiated
- 2021-06-30
- Posted
- 2022-04-05
- Terminated
- not on file
- Reason
- The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE Healthcare sent an Important Electronic Product Radiation Warning letter dated February 8, 2022 to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take. GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. For questions contact GE Healthcare Services at 1 (800) 437-1171 or local Service Representative.
- Quantity
- 273 (51 US; 222 OUS) in total
- Distribution
- Worldwide - US Nationwide distribution.
- Lot, serial or model codes
- Revolution CT, Revolution CT ES
- 510(k) numbers
- ["K133705","K163213","K191777"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28